NAFDAC raises alarm over circulation of fake antimalarial drug

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert warning Nigerians about the circulation of a counterfeit batch of Artemether/Lumefantrine tablets falsely branded as Aflotin 20/120.

According to a statement posted on the agency’s official X (formerly Twitter) account, the discovery was made following a report by Ajanta Pharma Limited, an India-based pharmaceutical company and the genuine manufacturer of the original medication.

Ajanta Pharma notified NAFDAC that a falsified version of its anti-malarial drug had surfaced in Nigeria, bearing batch number PA2128L. The company clarified that this batch was originally manufactured in December 2018 and expired in November 2020, under the brand name Combisunate 20/120 with a packaging format of 30 x 24 tablets.

However, the counterfeit product now in circulation is falsely labelled as Aflotin 20/120mg, repackaged in a different format—1 x 18 tablets—and features discrepancies in packaging and design.

“The overprinted matter on the falsified tablets does not match Ajanta’s printing style, and the artwork on the carton differs from our approved design,” the company noted.

Ajanta Pharma confirmed that it did not manufacture any product labeled Aflotin 20/120mg with batch number PA2128L, and therefore considers the version in circulation to be counterfeit.

NAFDAC has raised concerns about the serious health risks posed by counterfeit medicines, emphasizing that such products may fail to meet safety and efficacy standards, potentially resulting in ineffective treatment, harmful side effects, or even death.

The agency noted that genuine Aflotin 20/120 is a combination therapy containing Artemether (20mg) and Lumefantrine (120mg), commonly used in the treatment of uncomplicated malaria caused by Plasmodium falciparum.

The falsified version currently in circulation is fraudulently labelled with a manufacturing date of April 2023 and an expiry date of March 2026, and falsely lists Ajanta Pharma Limited with a Mumbai, India address as the manufacturer.

In response to the alert, NAFDAC has directed its zonal directors and state coordinators to step up surveillance and enforcement actions aimed at removing the counterfeit product from circulation.

The agency also issued a strong advisory to distributors, retailers, healthcare providers, and caregivers to verify the authenticity of medical products and ensure they are sourced exclusively from licensed and authorized suppliers.

Consumers and healthcare professionals are encouraged to report suspicious or substandard products to the nearest NAFDAC office or via the agency’s e-reporting platforms. Reports of adverse drug reactions or side effects are also welcomed through the same channels.